Internet Drug Outlet Identification Program. Progress Report for State and Federal Regulators: January 2013

Transcription

1 Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: January 2013

2 TABLE OF CONTENTS I. INTRODUCTION... 3 II. RESULTS... 4 A. Findings of Site Reviews... 4 B. Year-to-Year Comparison... 5 C. Recommended Internet Pharmacies... 6 D. Accreditation and Approval Programs... 6 III. PUBLIC HEALTH THREATS AND POLICY GAPS... 6 A. Prevalence of Counterfeit Drugs Online... 7 B. Illegal Online Sellers and Prescription Drug Abuse... 8 IV. OUTREACH, EDUCATION, AND COLLABORATION... 8 A. Patient Education... 8 B. Collaborative Efforts and Global Partners... 9 C. Major Internet Safety Initiatives in V. DISCUSSION VI. APPENDIX: Internet Drug Outlet Identification Program Criteria

3 INTERNET DRUG OUTLET IDENTIFICATION PROGRAM PROGRESS REPORT: January 2013 I. INTRODUCTION National Association of Boards of Pharmacy ( ) celebrates the fifth anniversary of its Internet Drug Outlet Identification Program in The program began like most initiatives, as an ambitious plan with a long name and wide-ranging potential to protect the public health. It was developed with three objectives: to identify Web sites selling prescription drugs illegally and endangering public health, to collect and provide data to support regulatory efforts to shut down rogue Internet drug outlets, and to educate and empower patients to make informed choices about buying drugs online. At the time the program launched in May 2008, already had been helping patients identify safe Internet pharmacies through its VIPPS (Verified Internet Pharmacy Practice Sites CM ) accreditation program for nearly a decade. It had become apparent, however, that illegal online drug sellers were outpacing legitimate pharmacies in monetizing the Internet s potential to reach consumers worldwide, blur jurisdictional boundaries, and skirt safety regulations. Through its research of Web sites selling prescription drugs, has found that the vast majority of online drug sellers are not legitimate pharmacies. During the same time period, reports of illegal online drug sellers, prescription drug abuse, and counterfeit medicine have proliferated around the world. In response, has expanded the scope of its outreach to public and private entities across state and national borders to raise awareness and find solutions. Today, finds itself in the company of a global coalition of exceptional stakeholders intent on eliminating the public health threats posed by rogue Internet drug outlets. Among other initiatives, the Association is joining forces with the global pharmacy community to develop the.pharmacy generic Top-Level Domain (gtld), a new online space exclusively for legitimate operators. 3

4 II. RESULTS A. Findings of Site Reviews: From the program launch in 2008 through the close of 2012, Internet Drug Outlets has conducted initial reviews and, via Reviewed by a subsequent review, verified its findings on 96.72% 10,275 Web sites selling prescription medicines. Of these, 9,938 (96.72%) were found to be operating out of compliance with 2.5% state and federal laws and/or patient 0.78% safety and pharmacy practice standards, and Not Recommendedd are listed as Not Recommended in the Potentially Legitimate VIPPS/Vet-VIPPS/ /e-advertiser Buying Medicine Online section, under Consumers, on the Web site. The percentagee of sites reviewed that have been designated as Not Recommended has held steady at approximately 97% for the last three years. It should be noted that the research findings reports herein and on the Not Recommended list include the total number of Web sites selling prescription drugs to United States patients that staff has reviewed and found to be out of compliance with US federal and statee pharmacy laws and standards of care, including those sites that were found to be noncompliant at the time of review but may since have been deactivated. Thanks to the successes off multistakeholder efforts to shut down rogue sites, many of these sites may now be defunct. It should also be noted that the numbers reported here do not represent the entire universe of Web sites selling prescription drugs illegally, but, rather, a representative e sampling of f the online environment over the last five years. The 9,938 Internet drug outlets currently listed as Not Recommendedd on the Web site are characterized as follows: 2,302 (23.2%) have a physical address located outside of the US (though most rogue sites do not post any address) 8,701 (87.6%) do not requiree a valid prescription 5,940 (59.8%) issue prescriptions per online consultation or questionnaire only 4,839 (48.7%) offer foreign or non-food and Drug Administration (FDA)-approved drugs 1,588 (16%) do not have secure sites, exposing customers to financial fraud and identity theft 3,874 (39%) have server locations in foreign countriess 4

5 1,121 (11.3%) dispense controlled substances Of the total 10,275 sites reviewed, 257 (2.5%) appear to be potentially legitimate, ie, meet program criteria that could be verified solely by looking at the sites and their domain name registration information. Eighty (0.78%) of the 10,275 reviewed sites have been accredited through s Verified Internet Pharmacy Practice Sites CM (VIPPS ) or Veterinary- Verified Internet Pharmacy Practice Sites CM (Vet-VIPPS ) programs, or approved through the e-advertiser Approval CM Program. The criteria against which evaluates Internet drug outlets are provided in the appendix of this report. Number of Sites 11,000 10,000 9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1, ,275 FINDINGS OF SITE REVIEWS 9, ,302 8,701 5,940 4,839 1,588 1,121 Site Description/Characteristic Findings of site reviews, in total, as of December 31, 2012 B. Year-to-Year Comparison: Since the program began, has reviewed an average of approximately 2,000 sites per year. As a result of site reviews completed in 2012, the Not Recommended list grew 18% in 2012 compared to the 8,456 sites listed by the end of 2011, clearly reflective of an ongoing problem. The percentage of sites reviewed that were designated as Not Recommended as of year-end 2012 (96.72%) is consistent with findings as of year-end 2011 (96.21%). 5

6 C. Recommended Internett Pharmacies:, alongg with many patient safety advocates, continues to recommend that USS patients use Internet pharmacies accredited through the VIPPS and Vet-VIPPS programs when buying medication online. These sites have undergone and successfully completed the thoroughh accreditation process, which includes a review of all policies and procedures regarding the practice of pharmacy and dispensing of medicine over the Internet, as well as an on-site inspection of facilities used by the site to receive, review, and dispensee medicine. Currently, 51 VIPPS and Vet-VIPPS pharmacy sites, representing more than 12,000 pharmacies, are listed as Recommended Internet Pharmacies. Several more applications are in progress. D. Accreditation and Approval Programs: In additionn to identifying rogue sites, the Internet Drug Outlet Identification program staff continues to assist in screening applicant Web sites for the VIPPS, Vet-VIPPS, and e-advertiser Approval programs. Sites that have received e-advertiser Approval status do not fill new prescription drug orders via the Internet, and thus, are ineligible for VIPPS, but accept refill requests from their existing customers, provide drug information or pharmacy information, or offer other prescription drug-related services. Sites that have received e- Advertiserr Approval status have been found to bee safe, reliable, and lawful. These sites are listed on the Web site as Approved e-advertisers. The standards that uses to screen e-advertiser Approval Program applicantss are posted in the e-advertiser Approval Program section, under Accreditation, on the Web site. As of December 31, 2012, there weree 29 entities listed on the Web site as Approved e-advertisers, and several more applications are in progress. III. PUBLIC HEALTH THREAT AND POLICY GAPS Education has been a primary objective of the Internet Drug Outlett Identification program since its inception in May In August 2008, reported the initial findings of its Web site reviews in the first Internet Drug Outlet Identification n Program forr State and Federal Regulators. distributed a survey later that year to the state boards of pharmacy and federal regulatory agencies to solicit input on the regulatory environment pertaining to Internet drug outlets, as well as feedback on the program, so as to better support their efforts. Results made it clear that further efforts in this area were needed. Survey results showed that most boards of pharmacy (73% of respondents) said it has been difficult (17%) or very difficult (56%) for their board or agency 6

7 to regulate Internet drug outlets. More than half (66%) of respondents said it is a high or very high priority for their board or agency to regulate Internet drug outlets. Respondents cited the following obstacles: lack of investigatory expertise, lack of or unclear jurisdiction, and lack of resources (eg, funding, personnel). The information contained in the report that respondents found most helpful was data on Web sites that dispense drugs without a valid prescription, and sites that do not provide the address of the pharmacy dispensing the drugs. In November 2009, expanded distribution of its progress report to include the states attorneys general and frequently receives additional requests to expand distribution. The reports also are posted on the Web site and are cited frequently in other publications. A. Prevalence of Counterfeit Drugs Online: Over the past five years it has become increasingly apparent that the likelihood of patients obtaining substandard or counterfeit drugs goes up substantially when online drug sellers are involved. The types of drugs counterfeited defy categorization. They include not only the so-called lifestyle drugs for baldness and erectile dysfunction, but also life-saving treatments for cancer and HIV, drugs that are in short supply in the legitimate supply chain, maintenance drugs that promise repeat business, and antivirals, especially in the midst of a public health epidemic such as the recent H1N1 and H5N1 influenza outbreaks. FDA has issued consumer warnings about counterfeit versions of various prescription and over-the-counter (OTC) drugs being sold over the Internet: Alli weight-loss pills in January 2010, generic Tamiflu in June 2010, phentermine in November In February 2012, FDA reported that multiple vials of counterfeit Avastin were purchased from online sellers by 19 medical clinics in the US and subsequently administered to cancer patients. A few months later, in April 2012, FDA reported a counterfeit version of Altuzan. Reports published in professional health journals also attest to the prevalence of counterfeit medicine on the Internet, including the International Journal of Clinical Practice (January 2010), American Journal of Health-System Pharmacy (November 2010), Drug Topics (December 2010), Journal of Pharmaceutical Sciences (June 2011), Journal of Sexual Medicine (August 2011), Vaccine (November 2011), and Journal of Medical Internet Research (February 2012). Such reports also have appeared in consumer and professional media, including articles in The New York Times, USA Today, Consumer Reports, and reports on CNBC and the Dr Oz Show, many of them citing as a source. Regulators and stakeholders in other countries, too, have warned consumers about the dangers of buying prescription drugs from unknown sources online, and several nations including China, Japan, 7

8 and the European Union have launched anti-counterfeiting campaigns to raise consumer awareness and stiffen criminal penalties. B. Illegal Online Sellers and Prescription Drug Abuse: Aside from the danger of obtaining substandard, tainted, or counterfeit medicine from online sellers, the easy access to addictive narcotic painkillers has likely contributed to increasing rates of prescription drug abuse. In May 2011, a study, Growing Internet Use May Help Explain the Rise in Prescription Drug Abuse in the United States, published in Health Affairs finds that, over a seven-year period, states with the greatest expansion in high-speed Internet access also had the largest increase in admissions for treatment of prescription drug abuse. The report stresses that the link between these phenomena cannot be ignored in devising effective solutions. Also in May 2011 at the 107 th Annual Meeting, held a continuing education session, Rogue Internet Pharmacies Can Collaboration Break the Link? The Alliance for Safe Online Pharmacies (ASOP) and jointly presented information on rogue Internet drug outlets, their contributing role in prescription drug abuse, and the need for collaborative efforts to tackle these problems and advance patient safety. IV. OUTREACH, EDUCATION, AND COLLABORATION A. Patient Education: The risks posed by illegal online drug sellers are particularly concerning because of the increasing numbers of consumers who purchase medicine online. The Partnership at Drugfree.org released study results in December 2010 indicating the prevalence of Americans (one in six) obtaining prescription medication via the Internet without a valid prescription. The promise of deep discounts and convenient access to prescription drugs continues to drive unwary consumers to illegal drug sites. Rogue online drug sellers, for their part, thrive on deceiving consumers into a false sense of security and the mistaken belief that any online pharmacy is as safe and reliable as the pharmacies they know. Patient education efforts seek to dispel this misconception and expose illegal online sellers as the drug dealers they are. In 2010, acquired the AWAR X E Consumer Protection Program, originally created in 2007 by the Minnesota Pharmacists Foundation in memory of Justin Pearson, who bought the prescription narcotics that killed him from an illegal online drug seller, to spread its medication safety message to a national audience. From 2010 to 2012, participated in multiple consumer expositions to educate patients and answer questions about the dangers of rogue Internet drug outlets and other medication safety concerns. In August 2011, launched its first advertising campaign, Does a Drug Dealer Lurk in Your Medicine Cabinet? 8

9 B. Collaborative Efforts and Global Partners: With the increase of prescription drug transactions taking place over the Internet, the need for collaboration with other public and private entities has become paramount. works in cooperation with several other associations, companies, coalitions, and agencies in the US and abroad to address the public health threat posed by illegal online drug sellers. Since 2008 has often worked with LegitScript, an Internet monitoring company that approves Internet pharmacies meeting -recognized standards and identifies rogue sites. has sent letters urging Internet Corporation for Assigned Names and Numbers (ICANN) and numerous US-based and foreign domain name registrars to enforce policies prohibiting the use of Web sites for unlawful purposes, and encouraging them to work with LegitScript to identify bad actors. In addition, has provided expert testimony in multiple trials involving rogue Internet drug outlets. Since 2010 has worked with search engines Google, Bing, and Yahoo! to block online advertisements for rogue Internet drug outlets. Also in 2010, became an observer to the ASOP, a nonprofit group that promotes Internet pharmacy safety through various legislative, professional, and consumer outreach efforts. participated in December 2010 with ASOP members and other stakeholders in the White House Intellectual Property Health and Safety Forum to address the problem of counterfeit medications and their frequent distribution over the Internet. In June 2011, participated with the Partnership for Safe Medicines and FDA in a Congressional briefing to discuss the problem of rogue Internet drug outlets. C. Major Internet Safety Initiatives in 2012: and, for that matter, the world, took on several major initiatives in 2012 to address the problem of rogue Internet drug outlets and the patient safety risks they pose. convened a Task Force on Internet Pharmacy Practice in March 2012 to review existing Internet pharmacy practices, current state laws and regulations, VIPPS standards, and the Model State Pharmacy Act and Model Rules of the National Associations of Boards of Pharmacy language, and to examine future opportunities and challenges in an emerging global environment. The task force recommended that work cooperatively with regulators and stakeholders worldwide to crack down on illegal online drug sellers, to block service providers that enable them to operate unhindered, and to push on in its bid to acquire and operate the.pharmacy gtld., with the support of a global coalition of stakeholders, applied to ICANN on March 30, 2012, to obtain and operate the.pharmacy gtld. The initiative marks a significant collaboration of public and private entities worldwide to curb the illegal sale of prescription drugs online and provide an exclusive space for legitimate Internet pharmacies. The program will restrict use of the 9

10 .PHARMACY domain to legitimate Web site operators that adhere to pharmacy laws specific to the jurisdictions in which they are located and to which they sell drugs. It is anticipated that ICANN will announce initial gtld application results in spring More information, as well as a full list of.pharmacy supporters, is available in the Programs section of the Web site. Several other significant events took place in 2012 involving international, multidisciplinary cooperation. In May 2012, participated in the National Governor s Association Center for Best Practices Prescription Drug Abuse Reduction Policy Academy Roundtable. In August 2012, hosted delegates of China s State Food and Drug Administration at its headquarters in August 2012 to discuss prescription drug regulation, particularly with regard to the Internet and illegal online drug sellers, and ways to foster safe and lawful Internet pharmacy practice. In September 2012, assisted the US Government Accountability Office (GAO) in compiling a study report on rogue Internet drug outlets, and worked with ASOP and other consumer safety advocates to support the Partnership at Drugfree.org by promoting its Medication Abuse Project Week of Action. V. DISCUSSION The events of 2012, and a recap of the five years since launched its Internet program, have shown that this is just the beginning. is proud to report the progress made to-date by its efforts combined with those of health care regulators, law enforcement, industry experts, and patient safety advocates worldwide that are committed to upholding the integrity of the practice of pharmacy, curtailing the online trade of illicit and counterfeit medications, and ensuring that patients have access to safe and effective prescription drugs. As we have seen, the combined efforts of multiple parties are a powerful force in bringing about positive change and protecting the public health, and the year ahead promises further improvement. For more information, please contact Melissa Madigan, policy and communications director, via at mmadigan@nabp.net. 10

11 VI. APPENDIX 11

12 Internet Drug Outlet Identification Program Criteria Patient Safety and Pharmacy Practice Standards 1. Pharmacy licensure. The pharmacy must be licensed or registered in good standing to operate a pharmacy or engage in the practice of pharmacy in all required jurisdictions. 2. DEA registration. The pharmacy, if dispensing controlled substances, must be registered with the US Drug Enforcement Administration (DEA). 3. Prior discipline. The pharmacy and its pharmacist-in-charge must not have been subject to significant recent and/or repeated disciplinary sanctions. 4. Pharmacy location. The pharmacy must be domiciled in the United States. 5. Validity of prescription. The pharmacy shall dispense or offer to dispense prescription drugs only upon receipt of a valid prescription, as defined below, issued by a person authorized to prescribe under state law and, as applicable, federal law. The pharmacy must not distribute or offer to distribute prescriptions or prescription drugs solely on the basis of an online questionnaire or consultation without a preexisting patient-prescriber relationship that has included a face-toface physical examination, except as explicitly permitted under state telemedicine laws or regulations. Definition. A valid prescription is one issued pursuant to a legitimate patient-prescriber relationship, which requires the following to have been established: a) The patient has a legitimate medical complaint; b) A face-to-face physical examination adequate to establish the legitimacy of the medical complaint has been performed by the prescribing practitioner, or through a telemedicine practice approved by the appropriate practitioner board; and c) A logical connection exists between the medical complaint, the medical history, and the physical examination and the drug prescribed. 6. Legal compliance. The pharmacy must comply with all provisions of federal and state law, including but not limited to the Federal Food, Drug, and Cosmetic Act and the Federal Controlled Substances Act (including the provisions of the Ryan Haight Online Pharmacy Consumer Protection Act, upon the effective date). The pharmacy must not dispense or offer to dispense medications that have not been approved by the US Food and Drug Administration. 7. Privacy. If the pharmacy Web site transmits information that would be considered Protected Health Information (PHI) under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CRF 164), the information must be transmitted in accordance with HIPAA requirements, including the use of Secure-Socket Layer or equivalent technology for the transmission of PHI, and the pharmacy must display its privacy policy that accords with the requirements of the HIPAA Privacy Rule. 8. Patient services. The pharmacy must provide on the Web site an accurate US street address of the dispensing pharmacy or corporate headquarters. The pharmacy must provide on the Web site an accurate, readily accessible and responsive phone number or secure mechanism via the Web site, allowing patients to contact or consult with a pharmacist regarding complaints or concerns or in the event of a possible adverse event involving their medication. 12

13 9. Web site transparency. The pharmacy must not engage in practices or extend offers on its Web site that may deceive or defraud patients as to any material detail regarding the pharmacy, pharmacy staff, prescription drugs, or financial transactions. 10. Domain name registration. The domain name registration information of the pharmacy must be accurate, and the domain name registrant must have a logical nexus to the dispensing pharmacy. Absent extenuating circumstances, pharmacy Web sites utilizing anonymous domain name registration services will not be eligible for approval. 11. Affiliated Web sites. The pharmacy, Web site, pharmacy staff, domain name registrants, and any person or entity that exercises control over, or participates in, the pharmacy business must not be affiliated with or control any other Web site that violates these standards. 13